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NCT Number: NCT07429162

Bacteriophage for Chronic Multidrug-Resistant Mycobacterium Abscessus Subsp. Abscessus Pulmonary Infection

The objective of this study is to evaluate mycobacteriophage therapy using in-vitro validated mycobacteriophage DP-QB-MYA-002 in combination with conventional antimycobacterial agents for the treatment of multidrug-resistant Mycobacterium abscessus pulmonary disease, with the goal of reducing mycobacterial burden and improving pulmonary outcomes.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Consent to participation

Exclusion criteria

  • non-consent to participation

Treatment and study plan

DP-QB-MYA-002

Biological

In-vitro effective Mycobacteriophage DP-QB-MYA-002 against specific strain of Mycobacterium abscessus ssp abscessuss

Primary outcomes

  1. Time to Sputum Culture Conversion (Microbiologic Response)

    Time frame: 1 year

    Serial AFB smear grading and serial mycobacterial sputum cultures during and post treatment

Secondary outcomes

  1. Change in Volume of Sputum Production (Clinical Response)

    Time frame: 1 year

    Patient Report

  2. Change in frequency of Cough (Clinical Response)

    Time frame: 1 year

    Patient Report

  3. Change in FEV1 (Clinical Response)

    Time frame: 1 year

    This will be assessed via spirometry at baseline and at the end of the study An increase in FEV1 indicating improvement in lung function or FEV1 decrease indicating decline in lung function.

  4. Change in BMI (Clinical Response)

    Time frame: 1 year

    Within subject change in BMI measured in kg/m^2. Increase in BMI as a sign of improvement. Decline in BMI as sign of decline or worse outcome.

  5. Radiographic Response

    Time frame: 1 year

    Chest imaging response (CT scan) to treatment. Reduction in size, number or density of pulmonary nodules indicating improvement, whereas increased size, number or density indicating worsening.

Other outcomes

  1. Adverse Effects (Clinical)

    Time frame: 1 year

    Adverse clinical and laboratory events (number and severity) on treatment

Sponsors and collaborators

Lead sponsor

Alberta Health services

Other

Registry information

Official study title

DP-QB-MYA-002 Phage Cocktail for Chronic Multidrug-Resistant (MDR) Mycobacterium Abscessus Subsp. Abscessus Pulmonary Infection

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 24, 2026
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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